System for umbilical catheter

ABSTRACT

A medical catheter or tube clamp or support structure that is secured to an infant and holds a medical tube in place to prevent the tube from pistoning (axially moving within the infant relative to the entry point). In one embodiment, the medical tube claim comprises a catheter securing system that further includes a base that further includes at least one base member, a tube support member integrally formed with at least one base member that allows the tube to be inserted into an umbilical cord or stub in a relationally secure manner to prevent the tube from pistoning within an infant, and at one least channel for receiving a tube or catheter of a specified size and for securing the tube or catheter.

CROSS REFERENCE TO RELATED PATENTS/S Provisional Priority Claim

The present U.S. Utility Patent Application is a ContinuationApplication of U.S. Utility patent application Ser. No. 13/109,835 filedMay 17, 2011 and issued as U.S. Pat. No. 8,617,115 on Dec. 13, 2013,which claimed priority to and was the utility application of theProvisional Applications for Patent listed below and claims prioritypursuant to 35 U.S.C. §10 119(e) to the following U.S. ProvisionalPatent Applications which are hereby incorporated herein by reference intheir entirety and made part of the present U.S. Utility PatentApplication for all purposes:

1. U.S. Provisional Patent Application Ser. No. 611,345,509, entitled“APPARATUS FOR UMBILICAL CATHETER,” 15 filed May 17, 2010.

2. U.S. Provisional Patent Application Ser. No. 611,384,267, entitled“APPARATUS FOR UMBILICAL CATHETER,” filed Sep. 18, 2010.

BACKGROUND

1. Technical Field

The present invention relates to medical devices and, more particularly,to fluid vessels for delivery of medicinal and nutritional flows and fordraining fluids from a patient.

2. Related Art

Fluid delivery systems are known to fill a great necessity for deliveryof medicine and nutrients to ill and disabled patients in many settingsespecially hospitals and health care facilities as well as for drainingfluids. For example, in neo-natal units, infants are often fed enterally(e.g., a tube inserted in the mouth or nasal opening and through thetrachea for delivery of the fluid to the stomach or intestinal region ofthe body) and are also provided medication and other fluidsintravenously. Medical tubes that are inserted into a patient's bodycavity, vessel or duct are known as catheters. Catheters are often usedfor draining urine and other undesired fluids as well as foradministering medication, nutrition, etc.

One challenge for delivery of fluids is that there exists a need formaintaining a particular fluid vessel such as a medical tube or catheterin a fixed location in relation to an entry point of the infant orpatient. Tubing that shifts or withdraws can injure the patient whetherthe patient is an adult or an infant. The shifting of a tube oftenoccurs in a reciprocating manner as a patient moves. Such motion in andout of the body is known as pistoning. The shifting of a tube, whetherpistoning or just in one direction into the patient can, in the case ofan infant having a catheter inserted through the umbilical stub, piercethe heart and kill the infant. Thus, often, medical tape is used to holdsuch umbilical catheters in place. The inventor has noted, however, thatmedical tape for this purpose is not reliable and an improved systemwould be desirable.

SUMMARY OF THE INVENTION

The present invention is directed to apparatus and methods of operationthat are further described in the following Brief Description of theDrawings, the Detailed Description of the Invention, and the claims.Other features and advantages of the present invention will becomeapparent from the following detailed description of the invention madewith reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the present invention can be obtained when thefollowing detailed description of the preferred embodiment is consideredwith the following drawings, in which:

FIG. 1 is a top view of a medical tube with an integrally formed clampfor securing the medical tube into a fixed location in relation to thepatient according to one embodiment of the invention.

FIG. 2 is a cutaway top view of a medical tube with an integrally formedclamp for securing the medical tube into a fixed location in relation tothe patient according to one embodiment of the invention.

FIG. 3 is a top view of a medical tube clamp according to one embodimentof the invention.

FIG. 4 is a side view of the medical tube clamp of FIG. 1 according toone embodiment of the invention.

FIG. 5 is an exploded view of two piece device medical tube clampaccording to one embodiment of the invention.

FIGS. 6 and 7 illustrate an alternative embodiment of the two-piecemedical tube clamp of FIGS. 3 and 4.

FIG. 8 is an exploded view of two piece device medical tube clampaccording to one embodiment of the invention.

FIG. 9 is a flow chart of a method according to one or more embodimentsof the invention.

FIG. 10 is a two-piece medical tube clamp according to an alternativeembodiment of the invention.

FIGS. 11-13 illustrate one embodiment of a tube support structure thatsupports a tube in a vertical position relative to an infant.

FIGS. 14-15 illustrate another embodiment of a catheter supportstructure that supports a tube in a vertical position relative to aninfant.

FIGS. 16-17 illustrate another embodiment of a catheter supportstructure that supports a tube in a vertical position relative to aninfant.

FIGS. 18-19 illustrate another embodiment of a catheter supportstructure that supports a tube in a vertical position relative to aninfant that has a circular base member that circumvents an umbilicalstub or cord.

FIG. 20 illustrates another embodiment of a catheter support structurethat supports a tube in a vertical position relative to an infant thathas a circular base member that circumvents an umbilical stub or cordand that has clamps to clamp the support structure to the umbilical cordor stub.

FIGS. 21 and 22 are side and top views, respectively, of a cathetersupport structure according to an embodiment of the invention.

FIG. 23 is a cutaway view of one end of a support member to illustrateone embodiment of the flanges and the securing tabs that combine todefine the channels for holding an umbilical catheter.

FIGS. 24 and 25 are cutaway views that illustrate alternativeembodiments of the flanges and tabs that define the channels for holdingan umbilical catheter.

FIG. 26 is an alternative embodiment of a support member that includesan upper end that curves down towards the umbilical stub.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of a medical tube with an integrally formed clampfor securing the medical tube into a fixed location in relation to thepatient according to one embodiment of the invention. A medical tube 02includes a primary tube 04 and two secondary tubes 04 a and 04 b forconducting fluids. As may be seen, tubes 04 a and 04 b are fluidlycoupled to tube 04. Thus, for example, if tubes 04 a and 04 b areconducting fluid from a patient, such fluid flows out of primary tube04. As may also be seen, medical tube 02 includes two eyelets 06 withinan integrally formed clamp 08 that allow the medical tube 02 to bestapled or sutured to the patient to keep medical tube 02 in arelatively fixed location.

FIG. 2 is a cutaway top view of a medical tube with an integrally formedclamp for securing the medical tube into a fixed location in relation tothe patient according to one embodiment of the invention. Generally,FIG. 2 illustrates that the medical tube 02 comprises a reinforcedperimeter of clamp 08 and about the eyelets 06 to structurally reinforceclamp 08 of medical tube 02.

Generally, it may be seen that the integrally formed tube clamp 08 maybe considered to be reinforced tabs that extend outwardly from a medicaltube with eyelets to secure the medical tube 02 to the patient. Thepresent specification and claims use the term “tube clamp” however,because, in other embodiments, the “tube clamp” is not formed integrallywith the medical tube and is used to securely hold a tube (e.g., acatheter tube) to the patient. These tube clamps comprise one embodimentof a catheter securing structure.

FIG. 3 is a top view of a medical tube clamp 10 according to oneembodiment of the invention. Medical tube clamp 10 is a medical devicefor attaching a tube into a fixed position in relation to a patient suchas, for example, an infant. Medical tube clamp 10 is a two-piece devicethat includes a lower portion and an upper portion that matingly engagewith each other about a tube such as a feeding tube to hold the tube inplace. The lower piece includes a perimeter portion 12. The upper piece14 is sized to fit within perimeter portion 12 in a snug manner torequire some force or energy to be removed. Accordingly, if a tube 16 islaid on top of the lower portion and then upper portion 14 is snapped orpush into mating engagement with the lower portion within perimeterportion 12, tube 16 is held in place. Medical tube clamp 10 includes twoeyelets shown generally at 18. Eyelets 18 define an opening showngenerally at 20. In the described embodiment, eyelets 20 allow medicaltube clamp 10 to be medically attached by means of a stitch or staple tothe infant or patient to hold medical tube clamp 10 in place in relationto the infant or patient. As may further be seen, medical tube clamp 10,and more particularly perimeter portion 12, defines openings 22 and 24to allow the tube 16 to enter/exit medical tube clamp 10.

FIG. 4 is a side view of the medical tube clamp 10 of FIG. 3 accordingto one embodiment of the invention. More particularly, defined openings22 and 24 may readily be seen in side view 26 of FIG. 4 generally at 28for allowing a tube such as tube 16 to enter/exit medical tube clamp 10.

FIG. 5 is an exploded view of two piece device medical tube clamp 10according to one embodiment of the invention. As described in relationto FIG. 3, medical tube clamp 10 included a lower portion, shown here at30, and upper portion 14. Lower portion 30 includes perimeter portion 12having defined openings 22 and 24. In one embodiment, lower portion 30includes a floor 32 that is used to secure a tube such as tube 16.Eyelets 18 of FIG. 3 comprise an inner eyelet wall 34 and outer eyeletwall 36. As may be seen, inner eyelet wall 34 is formed as a part oflower portion 30 while outer eyelet wall 36 is formed as a part of upperportion 14. Eyelet wall 34 defines opening 20. Eyelet wall 36 definesopening 38 which is sized to matingly engage inner eyelet wall 34. Upperportion 14 includes a body 40 that further defines a tabbed portion 42that is sized to matingly engage opening 24 of perimeter portion 12.

In operation, when upper portion 14 is matingly inserted within lowerportion 30:

an inner wall of outer eyelet 36 engages an outer wall of inner eyelet34;

tab 42 engages opening 24; and

an outer perimeter of body 40 of upper portion 14 engages an inner wallof perimeter portion 12.

Accordingly, because the sizing of these elements within upper portion14 and lower portion 30 and their associated eyelet walls are made tosnugly and tightly fit with each other when upper portion 14 is engagedwith lower portion 30, the two-piece medical tube clamp 10 operates tosecurely hold tube 16. Thus, when medical tube clamp-10 is properlyfixed to the patient (e.g., infant), the tube remains in a fixedposition in relation to the patient.

FIGS. 6 and 7 illustrate an alternative embodiment of the two-piecemedical tube clamp 10 of FIGS. 1 and 2. As shown in FIG. 6, thetwo-piece devices is shown generally at 50 which includes a perimeterportion 52 and an upper portion 54 that shaped differently from theircorresponding elements of FIGS. 3 and 4. A primary difference with theembodiment of FIGS. 6 and 7 is that medical tube clamp 50 is more squareor rectangular in shape rather than having the more rounded ends asshown in FIG. 3. Thus, outer perimeter 42 and upper portion 54 areshaped differently than the corresponding elements 12 and 14 of FIGS. 3and 4. Upper portion 54 having a body 62 thus is shaped to matinglyengage with outer perimeter 52. As all other elements other than theshape of the device and outer perimeters are the same as in FIGS. 3 and4, such common elements won't be described again. It should also benoted that other shapes may be used without deviating from the conceptsof the embodiments of the present invention. For example, eyelets 18 mayalso be formed in a non-circular shape (e.g., substantially square,rectangular, oval, etc.).

FIG. 8 is an exploded view of two piece device medical tube clamp 50according to one embodiment of the invention. As described in relationto FIG. 6, medical tube clamp 50 included a lower portion, shown here at60, and upper portion 54. Lower portion 60 includes perimeter portion 52having defined openings 22 and 24. In one embodiment, lower portion 60includes a floor 32 that is used to secure a tube such as tube 16.Eyelets 18 of FIG. 3 comprise an inner eyelet wall 34 and outer eyeletwall 36. As may be seen, inner eyelet wall 34 is formed as a part oflower portion 60 while outer eyelet wall 36 is formed as a part of upperportion 54. Eyelet wall 34 defines opening 20. Eyelet wall 36 definesopening 38 which is sized to matingly engage inner eyelet wall 34. Upperportion 54 includes a body 62 that further defines a tabbed portion 42that is sized to matingly engage opening 24 of perimeter portion 52.

In operation, when upper portion 54 is matingly inserted within lowerportion 60:

an inner wall of outer eyelet 36 engages an outer wall of inner eyelet34;

tab 42 engages opening 24; and

an outer perimeter of body 62 of upper portion 54 engages an inner wallof perimeter portion 12.

Accordingly, because the sizing of these elements within upper portion54 and lower portion 60 and their associated eyelet walls are made tosnugly and tightly fit with each other when upper portion 54 is engagedwith lower portion 60, the two-piece medical tube clamp 50 operates tosecurely hold tube 16. Tube 16, therefore, remains in a fixed positionin relation to the patient when medical tube clamp 50 is attached to thepatient (e.g., an infant).

FIG. 9 is a flow chart of a method according to one or more embodimentsof the invention. The method includes laying a bottom portion of atwo-piece tube clamp against a patient's skin (100). Thereafter, themethod includes laying a medical tube (e.g., a feeding tube) across abottom portion of two-piece tube clamp through entry and exits of thebottom portion that define a passageway for the tube (102). Thereafter,the method includes inserting an upper portion of the two-piece tubeclamp over the tube and into the lower portion of the two-piece tubeclamp to matingly engage the upper portion perimeter with the lowerportion perimeter (104). The method also includes, using medicalattachment means, attaching the two-piece clamp against patient skin(106). Medical attachment means include medical staples, stitches, etc.

While the two-piece clamp is attached to the patient, an alternativeembodiment of the inventive method includes removing the upper portionof the two-piece tube clamp to remove tube (108). Thereafter, the methodincludes laying new tube across bottom portion of the two-piece tubeclamp (110) and inserting the upper portion into lower portion over thenew tube to cause the upper portion to matingly engage the lower portion(112). In one embodiment, this step includes pushing anchors of one ofthe top and bottom portions of the two-piece tube clamp into anchoringports of the other of the top and bottom portions of the two-piece tubeclamp. For example, if the anchors are formed integrally with the upperportion and extend outwardly therefrom and if the anchoring ports areformed within the lower portion, the method includes pushing the upperportion into a defined space of the lower portion and also pushing theoutwardly protruding anchors into the anchoring ports.

FIG. 10 is a two-piece medical tube clamp 120 according to analternative embodiment of the invention. Medical tube clamp 120 includesinternal walls 122 that, in cooperation with a portion of outerperimeter 52, receives upper portion 124 wherein upper portion 124 issized to tightly fit within a space defined by internal walls 122 andouter perimeter 52. One advantage of the embodiment of FIG. 10 is that,after the two-piece medical tube clamp 120 has been attached to thepatient, the upper portion may be removed to change the tube that issecured by two-piece medical tube clamp without disturbing theattachment of two-piece 120 to the patient.

In one embodiment of the invention, an upper portion locking system isused to further increase a strength of the mating engagement of theupper and lower portions of the two-piece medical tube clamp 120. In thedescribed embodiment, a floor 126 of the lower portion of medical tubeclamp 120 defines a plurality of anchoring ports 128 that are sized toreceive and tightly hold a corresponding plurality of anchors 130 thatprotrude outwardly from a body 132 of upper portion 124.

In another embodiment of the invention, upper portion 124 includes abody 132 that further defines a tabbed portion 134 that is sized tomatingly engage opening 22 of perimeter portion 52 while tabbed portion42 matingly engages opening 24 of perimeter portion 52. It should beunderstood that tabbed portion 134 may also be included in otherembodiments such as those illustrated in relation to each of the figuresherein.

In premature and full term infants, a medical need often exists toinsert a catheter or medical tube through the umbilical stump (e.g.,into a vein) for a variety of purposes. Doing so, however, poses risks.If the catheter tube is not held in a stable manner, the tube may movewithin the infant along the vein with the adverse effect of damagingtissue that may endanger or fatally injure the infant. For example, thecatheter tube may slide too deeply and pierce the infant heart. Therealso may be a need for adults to use a tube supporting structure thatsecurely holds a tube and prevents pistoning.

Accordingly, there is a need for a structure (a tube structure that canclamp or secure a catheter tube) and a method for stabilizing a medicaltube, such as a catheter tube, in relation to the infant even while aninfant is moved for needed care or while the infant moves on its ownaccord. The various embodiments of the invention all include a cathetertube securing structure that stabilizes the catheter tube to preventmovement of the catheter in relation to the infant, or in other words,to prevent the tube from “pistoning” (sliding in and out) within theinfant vein or other anatomical element.

FIGS. 11-13 illustrate one embodiment of a catheter support structurethat supports a tube in a vertical position relative to an infant.Referring to FIG. 11, a catheter securing structure 204 is shown forstabilizing a catheter tube 208 that is placed into an umbilical cord orstub 212. Catheter securing structure 204 includes two upwardlyextending support members 206 a and 206 b and a supporting beam 216 thatextends between the two support members 206 a-b. Structure 204 alsoincludes securing elements 220 a and 220 b for securing tube 208.Structure 204 further includes base members 224 having rounded corners.In this embodiment, the base members 224 extend outwardly across theinfant body and may be taped or secured to the infant with a wrap tosecure the structure 204 about the umbilical cord 212 to securely holdtube 208 in place. This, therefore, stabilizes the tube in relation tothe infant to prevent pistoning.

The embodiment of FIG. 11 includes securing elements 220 a-b to securethe tube or catheter 208 to structure 204 in a desired manner. In oneembodiment, as is shown in the expanded view of the securing elements220 a-b having outwardly extending flanges 228, the tube is axiallyaligned to a direction parallel to the flanges 228 of securing elements220 a-b. The flanges 228 of the securing elements 220 a-b may be formedto securely receive a tube of a specified size. In one embodiment,flanges 228 of securing elements 220 a-b are shaped with tabs to receiveand hold tube 208. Alternatively, flanges 208 may be used to guide thetube in a specified direction with the intention that an adhesive wouldbe used to securely affix the tube to the structure. For example, apiece of tape may be used to secure the tube 208 to structure 204. Achannel defined by flanges 228 is sized to receive and hold the tube tothe structure. As should also be noted, securing element 220 a isoriented to direct the medical tube substantially vertically in relationto an infant laying on its back. More specifically, when the structure204 is attached or affixed to the infant, the tube is held in aperpendicular direction relative to the torso of the infant by securingelement 220 a.

FIG. 12 is a top view of securing structure 204 according to oneembodiment of the invention. FIG. 11 shows, for example, the beam 216,the securing elements 220 a and 220 b, and the flanges 228. FIG. 12 alsoshows the base members 224. FIG. 13 shows a front view of securingstructure 204 showing the same elements as FIGS. 11-12. As may be seenin the embodiment of FIG. 13, the two upwardly extending support members206 (206 a and 206 b) are sized differently. Here, support member 206 ais shorter in length than support member 206 b. Support member 206 b isformed to extend a necessary amount beyond beam 216 so that medical tube208 may readily bend between securing elements 220 a-b without kinkingas it changes direction to be vertically oriented by the securingelement 220 a to be directed into the umbilical stub 212.

FIGS. 14-15 illustrate another embodiment of a catheter securingstructure that supports a tube in a vertical position relative to aninfant. FIG. 14 illustrates a front view while FIG. 15 illustrates a topview of the tube support structure. Referring to FIG. 14 and FIG. 15, acatheter securing structure 230 is shown for stabilizing a catheter tube208 that is placed into an umbilical cord or stub. Catheter securingstructure 230 includes a supporting beam 234 and securing elements 242for securing tube 208. Structure 230 further includes base members 246having rounded corners 248. In this embodiment, the four base members246 extend outwardly across the infant body and may be taped to theinfant or wrapped to secure the structure 230 about the umbilical cordor stub (not shown here) to securely hold tube 208 in place to stabilizethe tube in relation to the infant to prevent pistoning of the tube. Asmay be seen, a first pair of base members 246, shown at 246 a, extendplanarly and away from each other.

Each of a second pair of base members 246, shown at 246 b, also extendsplanarly relative to the infant and away from each other. The two pairsof base members shown at 246 a and 246 b are on opposites sides ofstructure 230 and are structurally connected only by supporting beam 234that extends between two upwardly extending support members 250. The twoupwardly extending support members 250 extend upwardly from the twopairs of base members 246 shown at 246 a and 246 b, respectively.Additionally, this embodiment includes a tube support member 238 thatallows a medical tube or catheter to be securely held in place and toguide the medical tube or catheter into the umbilical stub or cord in aperpendicular manner relative to the infant body. In one embodiment,support member 238 includes securing elements 242 similar to flanges 228that are formed thereon to secure and guide tube 208 into a verticalposition (relative to the infant and stub 212 (not shown here) withoutkinking or bending tube 208 in a manner that fluid flow is inhibited. Inthe embodiment of FIGS. 16-17, however, the outer surface of tubesupport member 238 is sufficiently wide in relation to the tube to holdthe tube in place with some tape. Alternatively, support member 238 mayinclude flanges that define a channel that receives and securely holdstube 208.

FIGS. 16-17 illustrate another embodiment of a catheter supportstructure that supports a tube in a vertical position relative to aninfant. Referring to FIGS. 16-17, a catheter securing structure 252 isshown for stabilizing a catheter tube 208 that is placed into anumbilical cord or stub 212 (not shown here in FIGS. 16 and 17). FIG. 16illustrates a front view while FIG. 17 illustrates a top view of thecatheter securing structure. Structure 252 further includes base members254 having rounded corners 256. A tube or catheter support member 258 issimilar to tube support member 238 of FIGS. 14-15. In this embodiment, acircular or ringed base member 260 extends outwardly across the infantbody and may be taped to the infant to secure the structure 252 aboutthe cord or stub 212 (not shown here) to securely hold tube 208 in placeto stabilize the tube in relation to the infant to prevent pistoning.

Tube support member 258 allows a tube or catheter to be affixed tosecurely hold the tube or catheter and to guide the tube or catheterinto the umbilical stub or cord in a perpendicular manner relative tothe infant body. In one embodiment, support member 258 includes securingflanges that are formed thereon to secure and guide tube 208 into avertical position (relative to the infant and stub 212 (not shown here)without kinking or bending tube 208 in a manner that fluid flow isinhibited. In the exemplary embodiment of FIGS. 16-17, however, supportmember 258 does not include the securing flanges. Rather, it is sized toallow the catheter or tube to be taped to the support member whilesecurely holding the catheter or tube in a manner that guides the tubeor catheter into a vertical orientation in relation to the infant toenter the umbilical cord or stub.

In contrast to other catheter securing structures, described in relationto prior figures, structure 252 does not include a supporting beam.Structure 250 does include, however, the circular base ring 260 thatassists with stabilizing the catheter securing structure 252 against theinfant for stabilizing tube 208. As may be seen, base ring 260 is sizedto circumvent the umbilical stub or cord (after it has been cut). Here,ring 260 creates a structural coupling between the opposed pairs of basemembers 254 instead of a such structural coupling being achieved by wayof a beam as described before.

FIGS. 18-19 illustrate another embodiment of a catheter supportstructure that supports a tube relative to an infant or patient thatincludes a circular base member that circumvents an umbilical stub orcord or point of entry. Referring to FIG. 18, a top view of a cathetersecuring structure 270 is shown which comprises a circular base ring 274characterized by a sufficient width to securely hold structure 270against the infant body. A tube support member 278 extends outwardlyfrom base ring 274 and is shaped in a curvilinear manner to terminate ina substantially horizontal position relative to base ring 274 above thestub 212. Stub 212 is not shown here, but should be understood to belocated within base ring 274. Tube support member 278 may optionallyinclude securing flanges 282 for securely holding and guiding thecatheter tube. Such securing flanges 282 would be similar to thosedescribed before. In such an alternative embodiment of structure 270,flanges 282 radiate outwardly from ring 274 to support taping the basering 274 and structure 270 to the infant or patient.

FIG. 19 illustrates a side view of catheter support structure 270. Asmay be seen, tube 208 may be affixed to tube support member 278. Itshould be understood that tube support member 278 may readily besubstituted for other shapes such as, for example, support member 258 ofFIGS. 16-17.

FIG. 20 illustrates another embodiment of a catheter support structurethat supports a tube relative to an infant or patient that has acircular base member and that circumvents an umbilical stub or cord orentry point and that has clamps to clamp the support structure to theumbilical cord or stub. Referring to FIG. 20, a catheter securingstructure 290 comprises a circular base ring 294 characterized by asufficient width to securely hold structure 290 against the infant body.A tube support member 278 similar to that of FIGS. 18 and 19 extendsoutwardly from base ring 294 and is shaped in a curvilinear manner toterminate the tube in an axial position above the stub 212 (not shownhere). Additionally, as may be seen, structure 290 comprises a pluralityof clamps 298 that may be used to clamp or secure structure 290 to theumbilical cord or stub. The clamps 298 are ratcheting type clamps in oneembodiment. In another embodiment, as shown here, clamps 298 comprise athreaded bolt that may be screwed or turned to cause the clamps to beurged axially into or away from the umbilical cord or stub according tothe direction the bolt is turned.

FIGS. 21 and 22 are side and top views, respectively, of a cathetersupport structure according to an embodiment of the invention. Referringto FIG. 21, a side view of a catheter support structure 300 is shownwhich comprises a circular base ring 302 characterized by a sufficientwidth to securely hold structure 300 against the infant or patient body.In the described embodiment, base ring 302 has a 1.5 inch total diameterforming an opening that is 0.5 inches wide. Thus, the ring itself ischaracterized by a ½ inch width. Stated more technically, an outerradius of the ring is 0.75 inches while an inner radius of the ring is0.25 inches in one embodiment though alternative dimensions may be used.These dimensions are for one embodiment. The dimensions may readily beadjusted for other embodiments.

A tube support member 304 extends outwardly from base ring 302 and isshaped in a curvilinear manner to terminate in a horizontal positionabove the umbilical stub 212 (not shown here, but should be understoodto be located within the opening of base ring 302) or, more generally,an entry point of the patient. Tube support member 304 includes fivesecuring flanges 306 for securely holding and guiding the catheter tube308 though or in between flanges 306. As is shown more clearly in FIG.22, five flanges 306 extend outwardly from a base 310 of tube supportmember 304. As may further be seen, a peak height of base 310 of supportmember 304 is 0.5 inches above base ring 302. From that peak, base 310curves towards base ring 302 and slopes into base ring 302 in a mannerthat a catheter tube 308 inserted within flanges 306 towards base 310 ofsupport member 304 does not bend or kink in a manner that fluid flow isrestricted. As may be seen in FIGS. 21-22, a plurality of outwardlyextending tabs 312 extend outward from base ring 302 which tabs may beused to secure base ring 302 of structure 300 to the infant.

In the described embodiment, each of a plurality of tabs 312 extends ⅜″from base ring 312 (in one embodiment). These tabs 312 may, in oneembodiment, be made to be structurally flexible for securing to thecurved shape of the infant. While not shown explicitly, it should benoted that the various embodiments of the invention may include anovermold portion (especially if the securing structure such as tabs 312is made of an inflexible material) to improve comfort and/or acceptanceof the device by the infant. For example, at least the bottom portion orbase portion of structure 300 may be overmolded with a flexible material(e.g., silicon) to render the support structure more comfortable.

While tabs 312 are shown to extend from vertical and horizontal axis' itshould be understood that the orientation of tabs 312 may readily bechanged. For example, the tabs 312 may be rotationally shifted by about45 degrees to extend in a manner that there is no overlap between a tubeextending from support member 304 and any one of the tabs 312. As mayalso be seen, tabs 312 may include openings or apertures 320 that allowthe tabs to be sutured to another element, such as a gauze, to hold thesecuring structure in place. Alternatively, apertures 320 may bereplaced with protruding bumps to create a surface tension with a gauzeor other bandaging material to hold the securing structure 300 in place.

FIG. 22 illustrates a top view of securing structure 300. As may beseen, tube 308 may be secured to support member 304 by one of aplurality of channels defined by the spacing between the flanges 306. Inthe described embodiment, the five outwardly extending flanges arespaced to receive and secure only one of four specifically sized tubes.In the described embodiment, the flanges are disposed to create fourchannels that will securely hold, using the French Catheter scale, as isknown by those of average skill in the art, 3.5, 4.0, 5.0 and 8.0 FrenchCatheter scale tubes. A “1.0” of the French Catheter scale isapproximately 0.33750 millimeters. It should be understood that supportmember 304 may be made to have more or less that 5 flanges 306 to formmore or less than 4 channels that securely hold catheter tubes.Moreover, the flanges 306 may readily be disposed to form channels ofdifferent sizes to securely hold catheter tubes of different sizes. Asmay further be seen, each flange 306 includes at least two securing tabs308 protruding inwardly towards the channels 316 formed by the flanges306 to securely hold the catheter tubes. Moreover, the two widestchannels 316 (the two “bottom channels”) have at least three sets ofsecuring tabs 308 for securely holding catheter tubes. More or lessnumbers of securing tabs 308 may be used. In one embodiment, thesecuring tabs 308 extend along the majority of the length of thechannels 316 defined by flanges 306.

One aspect of the embodiment shown in FIGS. 21-22 is that catheter tubesmade from either silicon or urethane may be securely held by securingstructure 300, and, more specifically, by the combination of thechannels 316 formed by the flanges 306 and the securing tabs 308.

FIG. 23 is a cutaway view of one end of support member 304 to illustrateone embodiment of the flanges 306 and the securing tabs 308 that combineto define the channels 316. As may be seen, securing tabs 308 extendplanarly towards each other and away from flanges 306. Moreover, tabs308 and flanges 306 are shaped to form a passage way or channel 316 thatmatches, in size and shape, the outward perimeter of a correspondingtube (e.g., a 2.66 French, a 3.0 French, 3.5 French, 4.0 French, 5.0French or 8.0 French tube or other specified tube). In the embodiment asshown, four channels are defined for hold 3.5, 4.0, 5.0 and 8.0 Frenchtubes. Accordingly, the corresponding tube may be inserted into achannel 316 to be held in place at least in part by the tabs 308 andflanges 306.

FIGS. 24 and 25 are cutaway views that illustrate alternativeembodiments of the flanges and tabs that define the channels for holdingan umbilical catheter. As may be seen, tabs 308 have a planar verticalsurface in FIG. 24 and tabs 308 have a round endpoint surface in FIG.25. One advantage of tabs 308 of FIG. 25 is that the curved shapereduces the likelihood of a tube being damaged while forcibly insertedinto the channel 316 defined by flanges 306 and tabs 308.

FIG. 26 is an alternative embodiment of a support member 304 thatincludes an upper end that curves down towards the umbilical stub.Support member 304 includes an upper end 350 that curves down towardsthe umbilical stub to reduce bend (and not reduce flow rate) of acatheter tube as the tube extends from the support member 304 to theumbilical stub. Support member 304 includes 4 sets of tabs 308 disposedapproximately as shown to hold a catheter tube in place. It should beunderstood that support member 304 may include any of the aspectsdescribed in relation to the other figures including defining aplurality of channels to receive a corresponding plurality of tubes orcatheters of specified sizes. Further, in an alternative embodiment,tabs 308 may extend a substantial portion of/along support member 304thereby reducing the total number of tabs.

While the invention is susceptible to various modifications andalternative forms, specific embodiments thereof have been shown by wayof example in the drawings and detailed description. It should beunderstood, however, that the drawings and detailed description theretoare not intended to limit the invention to the particular formdisclosed, but, on the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the spiritand scope of the present invention as defined by the claims. As may beseen, the described embodiments may be modified in many different wayswithout departing from the scope or teachings of the invention. Forexample, the various exemplary embodiments of the tube securingstructures or clamps may readily include features or aspects that arecombined with other of the various embodiments of the tube securingstructures or clamps without departing from the spirit of the invention.

The invention claimed is:
 1. A catheter or tube securing system,comprising: a base configured to provide support for the catheter ortube securing system; a catheter or tube; a catheter or tube supportmember integrally formed with the base that allows the catheter or tubeto be vertically inserted into a patient in a relationally secure mannerto prevent the catheter or tube from pistoning within an infant when thebase is securely affixed to the patient; and wherein the catheter ortube is securely affixed to the catheter or tube support member andfurther wherein the base is configured to provide vertical support ofthe support member in orthogonal directions; and wherein the catheter ortube support member comprises at least one upwardly extending supportmembers and a supporting beam member that structurally extends betweenthe at least one upwardly extending support members.
 2. The catheter ortube securing system of claim 1 wherein the supporting beam membercomprises a channel that is shaped and sized to receive and securelyhold the catheter.
 3. The catheter or tube securing system of claim 1wherein the base comprises four outwardly extending base members.
 4. Thecatheter or tube securing system of claim 1 wherein the base comprises abase portion that can circumvent an umbilical stub.
 5. The catheter ortube securing system of claim 4 wherein the base comprises a base ring.6. The catheter or tube securing system of claim 1 wherein the basecomprises two eyelets that allow the catheter securing system to bestitched to the patient.
 7. A catheter or tube securing system,comprising: a base that further includes at least one base member; asupport member integrally formed with a substantially rigid materialintegral with the at least one base member and configured to hold a tubeor catheter away from the base and to direct the tube or catheter intoan umbilical cord or stub in a relationally secure manner to prevent thetube or catheter from pistoning within an infant; and the support membercomprising at least one channel for receiving the tube or catheter of aspecified size and for securing the tube or catheter; and wherein thesupport member comprises at least one upwardly extending support membersand a supporting beam member that structurally extends between the atleast one upwardly extending support members.
 8. The catheter or tubesecuring system of claim 7 wherein the at least one base member definesan aperture that can circumvent an umbilical stub.
 9. The catheter ortube securing system of claim 7 wherein the tube or catheter supportmember includes a plurality of channels and further wherein the at leastone channel is sized to receive and hold at least one of a 2.66, a 3.0,a 3.5, a 4.0, a 5.0 or an 8.0 French scale tube.
 10. The catheter ortube securing system of claim 7 wherein the base includes a plurality oftabs to facilitate securing the base against the infant.